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EC number: 700-093-4 | CAS number: 176969-34-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Jun 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted in 2004
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted in 2019
- Deviations:
- yes
- Remarks:
- limited details on model (barrier function, morphology, quality control), no check for direct MTT reduction or colour interference, acceptance and evaluation criteria differ from current guideline, no historical control data, no positive control included
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylic acid
- EC Number:
- 700-093-4
- Cas Number:
- 176969-34-9
- Molecular formula:
- C6H6F2N2O2
- IUPAC Name:
- 3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylic acid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: CellSystems, St. Katharinen, Germany
- Source strain:
- other: EST-1000 reconstructed human epidermis
- Details on animal used as source of test system:
- Not applicable
- Justification for test system used:
- Reconstructed human epidermis is the recommended test system for in vitro predicting of a corrosive potential.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EST-1000 (CellSystems, St. Katharinen, Germany)
- Tissue batch number: EST-90427-001
- Date of initiation of testing: 24 Jun 2009
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 min at room temperature and 60 min at 37.0 ± 2 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After the incubation period the tissues were carefully washed with PBS.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 2 h
- Spectrophotometer: EL808, Bio-Tek
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: A single experiment was performed.
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: The skin was moistened with 50 µL 0.9% NaCl and 25 mg of the solid test item were added on top of the skin tissues.
NEGATIVE CONTROL
- Amount applied: 50 µL - Duration of treatment / exposure:
- 3 and 60 min
- Number of replicates:
- triplicates for each treatment and control group
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 3 tissues
- Run / experiment:
- 3 min exposure
- Value:
- 94.43
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- The reliability of the test method was confirmed prior to the experimental study by interlaboratory validation.
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 3 tissues
- Run / experiment:
- 60 min exposure
- Value:
- 100.89
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- The reliability of the test method was confirmed prior to the experimental study by interlaboratory validation.
Any other information on results incl. tables
Table 1: Summary of results on skin corrosion
Sample | Exposure time | OD ± SD | % Viability |
Test item | 3 min | 1.68 ± 0.08 | 94.43 |
0.9% NaCl | 3 min | 1.78 ± 0.20 | 100.00 |
Test item | 60 min | 1.74 ± 0.11 | 100.89 |
0.9% NaCl | 60 min | 1.72 ± 0.14 | 100.00 |
OD: Optical densitiy, mean of 6 values
SD: Standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not corrosive
- Conclusions:
- The substance was tested for corrositivity in vitro according to OECD guideline 431 using reconstructed human skin as test system. The result revealed no corrosive property of the test item. There is regulatory acceptance in the EU that a substance can be considered corrosive (Skin Corrosive Cat.1A) based on a positive result in the human epidermis model test. Negative in vitro corrosivity responses are not conclusive with respect to non-classification or classification as irritant and shall therefore be subject to further evaluation.
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